FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
K Number: K091656
·
Decision Mar 11, 2010
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
18
Applicant Total
4
Review Days
275
Basic Information
- Device Name
- SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
- K Number
- K091656
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5880
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORGAN RECOVERY SYSTEMS, INC.
- Date Received
- June 9, 2009
- Decision Date
- March 11, 2010
- Product Code
- KDL
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KDL | Set, Perfusion, Kidney, Disposable | FDA class 2 | Gastroenterology, Urology |
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